Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris

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Using a left-right split face set up, the study evaluated the effect of sequential application of topical retinoid 0.1% gel and NSAID 5% gel in comparison with the sequential application of topical retinoid 0.1% gel and vehicle gel for the treatment of acne vulgaris.

Percentage Change in Inflammatory Lesions From Baseline to End of Treatment

Description

Percentage change in inflammatory lesions count from baseline to the e...

Description

Percentage change in inflammatory lesions count from baseline to the end of treatment

Time Frame

Baseline to End of treatment (4 weeks)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Topical Retinoid - Placebo

Topical Retinoid-NSAID

Arm/Group Description:

marketed topical retinoid : once da...

marketed topical NSAID : once daily...

Arm/Group Description:

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

marketed topical NSAID : once daily application, 4 weeks

marketed topical retinoid : once daily application, 4 weeks

Overall Number of Participants Analyzed

40

40

Median (Standard Deviation)

Unit of Measure: percentage of change

-20.3
(45.3)

-29.4
(37.0)

2.Secondary Outcome

Title

Non-inflammatory Lesions Count

Description

Percentage change in non-inflammatory lesions count from baseline to t...

Description

Percentage change in non-inflammatory lesions count from baseline to the end of treatment

Time Frame

Baseline to End of treatment (4 weeks)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Topical Retinoid - Placebo

Topical Retinoid-NSAID

Arm/Group Description:

marketed topical retinoid : once da...

marketed topical NSAID : once daily...

Arm/Group Description:

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

marketed topical NSAID : once daily application, 4 weeks

marketed topical retinoid : once daily application, 4 weeks

Overall Number of Participants Analyzed

40

40

Mean (Standard Deviation)

Unit of Measure: percentage of change

-41.4
(31.2)

-43.1
(37.6)

3.Secondary Outcome

Title

Total Lesions Count

Description

Percentage change in total lesions count from baseline to the end of t...

Description

Percentage change in total lesions count from baseline to the end of treatment

Time Frame

Baseline to End of treatment (4 weeks)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Topical Retinoid - Placebo

Topical Retinoid-NSAID

Arm/Group Description:

marketed topical retinoid : once da...

marketed topical NSAID : once daily...

Arm/Group Description:

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

marketed topical NSAID : once daily application, 4 weeks

marketed topical retinoid : once daily application, 4 weeks

Overall Number of Participants Analyzed

40

40

Mean (Standard Deviation)

Unit of Measure: percentage of change

-35.4
(24.0)

-39.9
(27.0)

4.Secondary Outcome

Title

Percentage Change in Total Lesions Count

Description

Percentage change in total leasions count from baseline to day 8

Description

Percentage change in total leasions count from baseline to day 8

Time Frame

Baseline to Day 8

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Topical Retinoid - Placebo

Topical Retinoid-NSAID

Arm/Group Description:

marketed topical retinoid : once da...

marketed topical NSAID : once daily...

Arm/Group Description:

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

marketed topical NSAID : once daily application, 4 weeks

marketed topical retinoid : once daily application, 4 weeks

Overall Number of Participants Analyzed

40

40

Mean (Standard Deviation)

Unit of Measure: percentage of change

-20.4
(24.1)

-21.1
(28.6)

5.Secondary Outcome

Title

Percentage Change in Total Lesions Count

Description

Percentage change in total lesions count from baseline to day 15

Description

Percentage change in total lesions count from baseline to day 15

Time Frame

Baseline to Day 15

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Topical Retinoid - Placebo

Topical Retinoid-NSAID

Arm/Group Description:

marketed topical retinoid : once da...

marketed topical NSAID : once daily...

Arm/Group Description:

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

marketed topical NSAID : once daily application, 4 weeks

marketed topical retinoid : once daily application, 4 weeks

Overall Number of Participants Analyzed

40

40

Mean (Standard Deviation)

Unit of Measure: percentage of change

-24.9
(24.3)

-22.2
(29.0)

6.Secondary Outcome

Title

Percentage Change in Total Lesions Count

Description

Percentage change in total lesions count from baseline to day 22

Description

Percentage change in total lesions count from baseline to day 22

Time Frame

Baseline to Day 22

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Topical Retinoid - Placebo

Topical Retinoid-NSAID

Arm/Group Description:

marketed topical retinoid : once da...

marketed topical NSAID : once daily...

Arm/Group Description:

marketed topical retinoid : once daily application, 4 weeks

vehicle gel : once daily application, 4 weeks

marketed topical NSAID : once daily application, 4 weeks

marketed topical retinoid : once daily application, 4 weeks

Overall Number of Participants Analyzed

40

40

Mean (Standard Deviation)

Unit of Measure: percentage of change

-35.7
(21.8)

-32.5
(30.0)

7.Secondary Outcome

Title

Investigator Global Assessment (IGA) of Disease Severity

Description

The investigator made an...

Description

The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe).

The outcome was the proportion of "success" (improvement of two grades of the IGA) from baseline to the end of treatment. “Success” is defined as improvement of two grades from the baseline assessment.

Adverse events were collected from study start untill 43 (±2)days after the last on-treatment visit if an AE (serious or non-serious) classified as possible or probably related to the study treatment was ongoing at the last on-treatment visit.

Adverse Event Reporting Description

[Not Specified]

Arm/Group Title

Topical Retinoid - Placebo, Topical Retinoid - NSAID

Arm/Group Description

[Not Specified]

Arm/Group Description

[Not Specified]

All-Cause Mortality

Topical Retinoid - Placebo, Topical Retinoid - NSAID

Affected / at Risk (%)

Total

--/--

Serious Adverse Events Serious Adverse Events

Topical Retinoid - Placebo, Topical Retinoid - NSAID

Affected / at Risk (%)

Total

0/40 (0.00%)

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

Prior to submitting or presenting a manuscript, the investigator shall provide to LEO Pharma a copy of all such manuscripts, and LEO Pharma shall have rights to review and comment. Upon the request of LEO Pharma the investigator shall remove any confidential information prior to submitting or presenting the manuscripts. The investigator shall, upon the request of LEO Pharma, delay publication or presentation to allow LEO Pharma to protect its inventions and other intellectual property rights.